On this page
Fasenra
benralizumab
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Fasenra
Proper name
benralizumab
Licence type
351(a)
BLA number
761070
Applicant
AstraZeneca AB
Center
CDER
Presentations
3
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 10MG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | April 5, 2024 |
| 30MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | November 14, 2017 |
| 30MG/ML | Injection | Subcutaneous | Autoinjector | Rx | October 3, 2019 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | September 17, 1931 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |